BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Non-Collagen Based

    PMA: P050038 · Decision Sep 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Non-Collagen Based
    Trade Name
    ARISTA AH ABSORBABLE HEMOSTAT
    PMA Number
    P050038
    Device Class
    FDA Class 3
    Product Code
    LMG
    Generic Name
    Agent, absorbable hemostatic, non-collagen based
    Regulation Number
    878.4490
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 26, 2006
    Date Received
    September 30, 2005
    Expedited Review
    N
    Docket Number
    06M-0396

    Advisory Committee Statement

    APPROVAL FOR THE ARISTA AH ABSORBABLE HEMOSTAT. THE DEVICE IS INDICATED FOR USE IN SURGICAL PROCEDURES (EXCEPT NEUROLOGICAL, OPHTHALMIC, AND UROLOGICAL) AS AN ADJUNCTIVE HEMOSTATIC DEVICE TO ASSIST WHEN CONTROL OF CAPILLARY, VENOUS, AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE AND OTHER CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LMG Agent, Absorbable Hemostatic, Non-Collagen Based